Health TrialsbyHealthPanel

Hydrate Heroes for Improving Brain Function & Mood

ConditionHydration Status
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of South Florida

About this trial

The primary goal of this 12-week randomized controlled study is to evaluate whether daily use of Hydrate Heroes results in measurable improvements in brain activity, mental health, and performance on cognitive tasks. By analyzing brainwave data, physical response metrics, and patient-reported outcomes, the study will demonstrate whether the supplement produces meaningful effects on mental and neurological health.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age between 18 and 65 years at time of consent.

Fluent in English (able to read, write, speak, and understand English).

Generally healthy, without chronic medical conditions (see Exclusion 10.3).

Willing and able to attend three in-person study visits over an approximate 12-week period (enrollment, ~6 weeks, ~12 weeks).

Disqualifiers

Neurological or Psychiatric Conditions

History of epilepsy, recurrent seizures, severe head injury, or other significant neurological disorders.

Current diagnosis of major psychiatric disorders (e.g., schizophrenia, bipolar disorder, severe major depressive disorder).

Chronic kidney disease, congestive heart failure, or any condition requiring medically supervised fluid restriction.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Hydrate Heroes (6 packets)

    Dietary supplement

    Participants that are randomized to the active comparator groups will receive 6 packets of Hydrate Heroes to use daily.

  • Hydrate Heroes (3 packets)

    Dietary supplement

    Participants that are randomized to the active comparator groups will receive 3 packets of Hydrate Heroes to use daily.

Treatment groups

48 Participants
are divided into 3 treatment groups
Group A: Hydrate Heroes AActive comparator 1 intervention
Group B: Hydrate Heroes BActive comparator 1 intervention
Group C: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Electroencephalography - Frequencies

Measurement of brain electrical activity. Measures will include power band analysis (e.g., delta, theta, alpha, beta, gamma) summed over activities and comparisons made between groups (i.e. ratios).

Time frame
12 weeks
2

Electroencephalography - ERP Amplitude

Measurement of brain electrical activity. Event-related potentials will be determined from events that occur during the activities. Differences in P300 amplitude will be determined (uV).

Time frame
12 weeks
3

Electroencephalograpy - ERP Latency

Measurement of brain electrical activity. Event-related potentials will be determined from events that occur during the activities. Differences of P300 latency will be determined between groups (msec).

Time frame
12 weeks

Secondary outcomes

1

Patient Reported Outcomes Measurement Information System (PROMIS)-29 + 2

This single form patient reported outcome provides insight to pain, depression, anxiety, sleep, and physical function. Score will be reported as a t-score. The average t-score is 50. Deviation from 50 demonstrates magnitude of difference in either positive or negative direction.

Time frame
12 weeks
2

International Physical Activity Questionnaire - Short Form (IPAQ-SF)

Patient reported outcome of physical activity over a 7-day period. The scores provide both a categorical output of 'Inactive', 'Slightly Active', and 'Active' and a continuous variable of metabolic equivalent (MET).

Time frame
12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of South Florida

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: